[Note: This is industry-derived information]
Allergan plc (AGN), (NYSE: AGN), a leading global
pharmaceutical company, today announced positive results from CGP-MD-01, a
Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of
orally administered atogepant. All active treatment arms of atogepant met the
primary endpoint across all doses and dose regimens, with a statistically
significant reduction from baseline in monthly migraine/probable migraine (MPM)
headache days in patients with episodic migraine treated with atogepant compared
with placebo for 12 weeks. Atogepant is Allergan's second orally-administered
investigational calcitonin gene-related peptide (CGRP) receptor antagonist in
development for migraine prevention.
Atogepant follows ubrogepant, Allergan's first oral investigational CGRP
antagonist for the acute treatment of migraine, which reported two positive
Phase 3 pivotal trial results earlier this year. Allergan will continue with
its phase 3 program for atogepant following discussions with regulatory
authorities.
In study CGP-MD-01 834 U.S. adult patients were randomized
(2:1:2:1:2:1) to placebo, 10-mg QD, 30-mg QD, 30-mg BID, 60-mg QD, and 60-mg
BID respectively, and treated under double blind conditions 12 weeks for the
prevention of episodic migraine. Efficacy analyses were based on the modified
ITT (mITT) population of 795 patients.
The primary efficacy endpoint was the change from baseline in mean
monthly migraine/probable migraine (MPM) headache days across the 12-week
treatment period.
All active treatment groups demonstrated a statistically
significant reduction from baseline in the primary efficacy parameter (10 mg QD
vs placebo, p=0.0236; 30 mg QD vs placebo, p=0.0390; 60 mg QD vs placebo, p=0.0390;
30 mg BID vs placebo; p=0.0034, 60 mg BID vs placebo, p=0.0031). The reported p-values are adjusted for
multiple comparisons by controlling the overall type I error rate of the study
at 5%, 2-sided.
Primary endpoint: change from baseline in mean monthly
migraine/probable migraine (MPM) headache days across 12-week treatment period
– mITT population…
Additional details and results from other endpoints are
anticipated to be presented at upcoming scientific meetings.
"We are extremely pleased to share these positive
results for atogepant -- our first phase 2b/3 study in Episodic Migraine—which
represent a tremendous opportunity in the prevention of migraine, with a
convenient, oral dosage form that is currently unavailable," said David
Nicholson, Chief Research and Development Officer, Allergan. "Allergan has
been studying migraine treatment for decades and is committed to addressing
unmet needs through product innovation for patients who are hopeful for new
options that can make a true difference in their daily lives."
In the CGP-MD-01 trial, atogepant was well tolerated. The most common adverse events were nausea,
fatigue, constipation, nasopharyngitis, and urinary tract infection which were
reported with a frequency >5% in at least 1 atogepant treatment arm and
greater than placebo. There was no
signal of hepatotoxicity with atogepant in this study with daily administration
over 12 weeks. The liver safety profile
for atogepant was similar when compared to placebo…
"These exciting results demonstrate the potential for
atogepant for a broad spectrum of migraine patients. The efficacy and safety
across doses and dose regimens show promise in a patient population with high
unmet treatment needs," said Dr. Peter Goadsby, Neurologist and Professor
at Kings College, London and University of California, San Francisco.
"Results from this atogepant trial provide continued evidence for the
clinical potential of oral CGRP antagonists and the substantial value of
progressing research and developing new treatments for migraine patients."
https://seekingalpha.com/pr/17188016-allergans-oral-cgrp-receptor-antagonist-atogepant-demonstrates-robust-efficacy-safety
Courtesy of: http://practicalneurology.com/news/?id=51792¢er=39&utm_campaign=Neurologywire&utm_source=hs_email&utm_medium=email&utm_content=63793296&_hsenc=p2ANqtz-_bTbAEn78-DxhIRbTyxe51z1BJ4nfzTgIjGDQOpeIBNv4IHe2xqJXGJ1BYjsrS1uMu47rbG-1diFnobtkXAh97tVFItXKO0ryoxm2hJKVKKHMAdrQ&_hsmi=63793296
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